Chronic Renal Failure
Conditions
Keywords
glucose intolerance, insulin, microvascular function, genotyping, CYP3A5, pharmacokinetics, renal transplantation
Brief summary
Our primary aim is to investigate if cyclosporine A reduces insulin secretion.
Detailed description
Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.
Interventions
DRUGcyclosporine A
Sponsors
University of Oslo School of Pharmacy
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Renal failure patients on dialysis which is planned to receive a renal transplant
Exclusion criteria
* Age below 18 years or above 75 years * Pregnancy * Breast feeding mothers * Diabetes mellitus /WHO criteria) * Dialysis treatment less than 2 months * Serious coronary heart disease * Unstable angina pectoris * Recent acute infarction (less than 3 months) * Non-compensated heart failure * Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin secretion | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral insulin sensitivity | — |
| Endothelial function | — |
| Pharmacokinetics | — |
Countries
Norway
Outcome results
None listed